Biopharma Business

Tag "EU"

Brexit: Implications for the Pharma Industry in Ireland

    Brexit: Implications for the Pharma Industry in Ireland

The UK’s referendum decision to leave the EU in May 2016 undoubtedly sent shockwaves throughout Europe. European countries are still struggling to interpret what ‘Brexit’ will mean for them. Ireland,

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Commission not ranking preferences for key EU agencies post-Brexit

    Commission not ranking preferences for key EU agencies post-Brexit

The publication on Saturday of the EU Commission’s unranked and unshortlisted assessment of the 27 bids from member states to host the London-based European Banking Authority (EBA) and the European

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British manufacturing industry calls on government to rethink Brexit strategy

    British manufacturing industry calls on government to rethink Brexit strategy

British manufacturers are asking the government to negotiate access to the single market and a form of customs union along with suitable transition period. The call comes from EEF, the

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Novo Nordisk wins European approval for Refixia

    Novo Nordisk wins European approval for Refixia

Novo Nordisk has won EU approval for its new haemophilia drug Reflixia and is planning its first European launches in the fourth quarter. The European Commission marketing authorisation comes one

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NHS could lose more than 2,000 GPs through Brexit

    NHS could lose more than 2,000 GPs through Brexit

GP leaders are warning that nearly 3.5 million patients are at risk of losing their family doctor, if the status of doctors from the European Union is not protected during

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Final deadline to notify hazardous mixtures with Spanish poison centre

    Final deadline to notify hazardous mixtures with Spanish poison centre

Business placing products on the market in Spain must notify their products ahead of 1 June 2017 or risk enforcement by the Spanish Authorities Businesses that place mixtures with a

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Ready, steady, go: Tightened EU medical device regulations are here

The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR). The next step is a transition period of three years for

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May the fourth be with you: IVD Symposium to take place in Dublin

On 4 May, the in vitro diagnostic medical device industry will gather in Dublin for an All-Ireland IVD Symposium on the new European regulation. Mani Subramani, head of business support,

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EU expands use of Janssen’s Darzalex

EU regulators have expanded the scope of Janssen’s Darzalex to include patients with multiple myeloma who have received at least one prior therapy, when given in combination with lenalidomide and

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Novartis’ lung cancer drug combination receives EU approval

The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). The

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Article 50: what does it mean for the UK’s medtech sector?

Now that the die has been cast, it’s time for the deal-making process to begin – if indeed a deal is on the cards. It seems that every time a

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Debiopharm’s triptorelin 6-month formulation receives EU approval

Debiopharm International, a Swiss-based company, part of Debiopharm Group, announced that triptorelin 6-month formulation (Decapeptyl and Pamorelin 22.5 mg) received approval for the treatment of central precocious puberty (CPP) in

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Coping mechanism: How businesses can deal with Brexit

Frost & Sullivan, Gary Jeffery comments on the implications of Brexit for businesses both in and out of the UK. Theresa May set out an ambitious plan of maintaining a

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Innovus Receives EU Okay to Market Sensum+ Cream

Innovus Pharmaceuticals, Inc., an emerging over-the-counter consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to

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The potential consequences for cancer care and cancer research of Brexit

In an editorial published in the journal ecancermedicalscience, leading academics from across the UK explore the risks facing cancer care, treatment and research in a post-Brexit world. The editorial is

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EU and US Pledge to Recognize Each Other’s GMP Inspections

In a landmark decision, the United States FDA and the European Commission announced on March 2, 2017 that they will recognize each other’s inspection assessments at pharmaceutical manufacturing facilities. The Mutual

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MEPs criticise lack of transparency on R&D costs

Price rises in the EU stir Members of European Parliament to discuss ways to make medicines more affordable, including increasing clarity on R&D costs New medicine prices in the EU

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